Industry News

- Read more about US FDA accepts Minerva Neurosciences' IND for MIN-101 to treat schizophrenia
Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat CNS disorders, announced that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia.
- Read more about USFDA Grants Orphan Drug Designation to Pluristem’s PLX-PAD Cells for Treatment of Severe Preeclampsia
Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced that the U.S. Food and Drug Administration has granted the Company’s PLX-PAD cells Orphan Drug Designation in the treatment of severe preeclampsia. Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in approximately 1% of pregnancies in Western countries.
- Read more about Eisai completes acquisition of Chinese Generic Pharmaceutical company Liaoning Tianyi Biological Pharmaceutical co., Ltd.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that regarding the acquisition of Chinese generic pharmaceutical company Liaoning TianYi Biological Pharmaceutical Co., Ltd. (Location: Benxi, Liaoning Province, China) previously announced on November 27, 2015, the conditions of transfer have been arranged, including receiving a new business license from the regulatory authority in China, and the acquisition has been completed.
- Read more about BioMarin announces that FDA will not take action on the Kyndrisa™ NDA by the PDUFA date
BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.
- Read more about Faron Pharma recruits first patient in Pan-European phase III INTEREST study to treat ARDS
Faron Pharmaceuticals Ltd (Faron), the clinical stage biopharmaceutical company, has announced the enrollment of the first patient in the phase III INTEREST clinical programme for Traumakine for the treatment of acute respiratory distress syndrome (ARDS). Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs.
- Read more about FDA Grants Rare Pediatric Disease Designation to REGENXBIO's RGX-111 Gene Therapy
REGENXBIO Inc. a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-111, the Company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis Type I (MPS I).
- Read more about Amarantus Requests RPDD and ODD from US FDA to treat GCMN with Engineered Skin Substitute
Amarantus Bioscience Holding Inc. , a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.
- Read more about Lupin receive FDA approval for generic Femhrt tablets
Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement.
- Read more about Dengvaxia, First dengue vaccine approved in Brazil
Sanofi Pasteur, the vaccines division of Sanofi, announced that Brazil has granted regulatory approval to Dengvaxia®, representing the third successful licensure of the dengue vaccine, which was also approved in Mexico and the Philippines earlier this month.
- Read more about Exelixis Completes Submission of NDA for Cabozantinib for Advanced Renal Cell Carcinoma Treatment
Exelixis, Inc. announced that it has completed the submission of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Exelixis has requested Priority Review as part of the NDA filing.